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NCT06728410 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
A Phase 2 study of Intrahepatic Cholangiocarcinoma and FGFR2 Gene Mutation, sponsored by Mehmet Akce.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT06728410: Recruiting Phase 2 study of Intrahepatic Cholangiocarcinoma and FGFR2 Gene Mutation, sponsored by Mehmet Akce.
NCT06728410 is a Phase 2 study of Intrahepatic Cholangiocarcinoma and FGFR2 Gene Mutation that is actively recruiting participants, run by Mehmet Akce. The registered enrollment target is 38 participants, below the 133-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06728410, a Phase 2 study of Intrahepatic Cholangiocarcinoma and FGFR2 Gene Mutation, is actively recruiting participants, sponsored by Mehmet Akce.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.
Primary Outcome
ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST version 1.1. A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Pemigatinib
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2026-01-27 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT06728410 shows while recruiting
NCT06728410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT06728410 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06728410 about?
NCT06728410 is a clinical study titled "A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement". This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administere...
What is the current status of trial NCT06728410?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2026-01-27. Estimated completion is 2027-07.
What conditions does trial NCT06728410 study?
This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma, FGFR2 Gene Mutation, FGFR2 Gene Rearrangement.
What interventions are being tested in trial NCT06728410?
The interventions under investigation include: Durvalumab (DRUG), Pemigatinib (DRUG).
Who is sponsoring clinical trial NCT06728410?
This trial is sponsored by Mehmet Akce, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06728410 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06728410's enrollment target sits among peer trials
38 14th of 17 higher than 4 of 17 other Intrahepatic Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intrahepatic Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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